) recently announced European Commission (EC) approval of its renal
cell cancer drug, Inlyta (axitinib). Inlyta gained approval from
the EC for use in treatment-failed patients (prior treatment with
Sutent (sunitinib or a cytokine) with advanced renal cell carcinoma
Approval was largely expected as, earlier this year, the
Committee for Human Medicinal Products (CHMP) of the European
Medicines Agency (EMA) had issued a positive opinion regarding
Pfizer had announced the submission of its EU marketing
application for Inlyta in June 2011. The regulatory filing was
based on phase III data from the AXIS trial. The AXIS trial, which
was conducted in patients with previously treated advanced renal
cell carcinoma, showed that patients in the Inlyta arm experienced
a significant improvement in progression free survival (median of
6.8 months versus 4.7 months) compared to patients being treated
) Nexavar (sorafenib).
The EU approval of Inlyta will provide advanced renal cell
carcinoma patients, especially previously-treated patients, with an
additional treatment option. We note that Inlyta gained approval
earlier this year in the US. Other countries where Inlyta is
already approved include Switzerland, Japan, Canada, Australia, and
Korea. Pfizer is currently conducting a phase III study with Inlyta
in treatment-naïve patients suffering from renal cell carcinoma.
Besides Inlyta, Pfizer has two drugs approved for kidney cancer -
Sutent and Torisel.
We currently have a Neutral recommendation on Pfizer, which
carries a Zacks #3 Rank (short-term Hold rating). While near-term
earnings will be driven by cost cutting efforts and share
repurchases, longer-term growth will depend on the success of drug
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